Full Press Release Details
Announces Strategic Reprioritization and Cost Restructuring Plan
-- Pipeline focus will
prioritize programs in immunology, including REZPEG
and several immunology research programs --
-- Development of NKTR-255
in diffuse large B-cell lymphoma and bladder cancer to continue
as strategic partnering options are pursued --
-- Cost restructuring
plan reduces San Francisco-based workforce by approximately 60% and
extends cash runway into the middle of 2026 --
-- Company to announce
financial results for the first quarter of 2023 after close of U.S.-based
financial markets on May 9, 2023 --
SAN FRANCISCO, April 17, 2023 -- Nektar
Therapeutics (Nasdaq: NKTR) today announced a strategic reprioritization and cost restructuring plan that includes a new pipeline focus
on immunology, as well as several cost reduction initiatives, which the company expects will significantly reduce future operating expenses
and extend its cash runway into the middle of 2026.
Key elements of the new plan include:
"Following a comprehensive review of
our portfolio, we have made the decision to prioritize the advancement of our immunology programs," said Howard W. Robin, President
and CEO of Nektar. "We intend to work with Eli Lilly either to continue REZPEG's development in the clinic under our existing agreement or to regain the
rights to REZPEG for Nektar. We believe the strong data generated for this asset demonstrates its potential as a remittive therapy in
atopic dermatitis and sets the stage to move quickly into a Phase 2b study. REZPEG would be positioned as a novel potential therapeutic
in a significant, growing biologic treatment landscape."
"The strategic initiative we announced
today is intended to further streamline our operations and to extend considerably our cash runway into the middle of 2026," continued
Robin. "Although the actions we are taking today are difficult, we are incredibly grateful for the contributions of the employees departing Nektar."
cash equivalents, and marketable securities of approximately $456 million as of March 31, 2023. These significant reductions in
the company's operating expenses, including personnel-related costs and external expenses, are expected to extend the
company's cash runway into the middle of 2026. Projected annual savings from the headcount reduction will be fully realized in
2024 and represent an annual savings of approximately $30 million. Nektar expects non-recurring cash payments of approximately $8
million, primarily in the second quarter of 2023 associated principally with the workforce reduction.
Executive Management Changes
of this initiative, Nektar also announced several changes to its executive team:
The company thanks its departing executives for their contributions to Nektar.
Conference Call Details to Announce First
Quarter 2023 Financial Results:
Nektar will announce its financial results
for the first quarter 2023 on Tuesday, May 9, 2023, after the close of U.S.-based financial markets. Howard W. Robin, President and Chief
Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.
The press release and live audio-only webcast
of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: http://ir.nektar.com/.
The web broadcast of the conference call will be available for replay through June 4, 2023.
To access the conference call, please pre-register
at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical
company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of
approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional manufacturing operations in Huntsville,
Alabama. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
About Rezpegaldesleukin (REZPEG)
Autoimmune and inflammatory diseases cause
the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms
enables the formation of the pathogenic T lymphocytes that conduct this attack. REZPEG is an investigational, potential first-in-class
T regulatory cell stimulator that may address this underlying immune system imbalance in people with many autoimmune and inflammatory
conditions. It is designed to target the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory
immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance. REZPEG
is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.
NKTR-255 is a biologic that targets the IL-15
pathway in order to activate the body's innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255
is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and
durable anti-tumor immune response.
Preclinical findings suggest NKTR-255 has
the potential to synergistically combine with antibody-dependent cellular cytotoxicity molecules as well as to enhance CAR-T therapies.
A Phase 2/3 study is underway that combines NKTR-255 with approved CAR-T cell therapies in patients with diffuse large B-cell lymphoma,
which is currently recruiting (NCT05664217).
There are two ongoing investigator sponsored
trials (ISTs) evaluating NKTR-255 following treatment with a CAR-T cell therapy. Fred Hutchinson Cancer Center is conducting a Phase 1
study evaluating NKTR-255 in combination with CD19 CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphoma (NCT05359211),
and Stanford University is conducting a Phase 1 study evaluating NKTR-255 in combination with CD19/22 CAR-T cell therapy in patients with
relapsed or refractory B-cell acute lymphoblastic leukemia (NCT03233854).
Cautionary Note Regarding Forward-Looking
This press release contains forward-looking
statements which can be identified by words such as: "will," "may," "advance," "support," "develop,"
"provide," "expect," "aim," "potential" and similar references to future periods. Examples
of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for
rezpegaldesleukin, NKTR-255 and our other drug candidates in research programs, the prospects and plans for our collaborations with other
companies, the timing of the initiation of clinical studies and the data readouts for our drug candidates, our expectations regarding
our 2023 cost restructuring plan and reduction in our San Francisco-based workforce, including the anticipated cost savings and non-recurring
cash payment related to, and the timing for completion of, the cost restructuring plan, and our expected working capital and cash runway.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current
beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends,
the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may
differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking
statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements
include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-255 and our other drug candidates
are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin,
NKTR-255 and our other drug candidates are investigational agents and continued research and development for these drug candidates is
subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings
in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-255 and our other drug candidates are in various stages of
clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing
of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused
by the COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards
of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately
obtaining regulatory approval in one or more important markets; (v) we may not achieve the expected cost savings we expect from our 2022
corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and
cost-saving activities in the future, (vi) patents may not issue from our patent applications for our drug candidates, patents that have
issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other
important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February